Cleared Traditional

K130065 - BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE

K130065 is an FDA 510(k) clearance for BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE, manufactured by Biosonic Technologies, LLC. The device is a Class 2 Neurology device with product code NFO cleared through the Traditional 510(k) pathway after a 475-day FDA review.

K130065 · Biosonic Technologies, LLC · Neurology device
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Apr 2014
Decision
475d
Days
Class 2
Risk

K130065 is an FDA 510(k) clearance for the BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Biosonic Technologies, LLC (Laguna Niguel, US). The FDA issued a Cleared decision on April 30, 2014 after a review of 475 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Biosonic Technologies, LLC devices

FDA 510(k) Submission Details - K130065

510(k) Number K130065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2013
Decision Date April 30, 2014
Days to Decision 475 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
327d slower than avg
Panel avg: 148d · This submission: 475d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFO Device Classification - Class 2, Special Controls

Product Code NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.